Medicaid savings from the Contraceptive CHOICE Project: a cost-savings analysis

Background Forty-five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. Objective The purpose of this study was to conduct a cost-savings analysis of the Contraceptive CHOICE Project, which provided counseling and no-cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. Study Design The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive-age women who were enrolled between 2007 and 2011. Study follow-up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. Results Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was $4.0 million vs$2.3 million for the comparison group. The estimated numbers of unintended pregnancies and births averted among the simulated Contraceptive CHOICE Project group compared with the comparison group were 927 and 483, respectively, which represented a savings in pregnancy and maternity care of $6.7 million. We estimated that the total cost savings for the state of Missouri attributable to the Contraceptive CHOICE Project was$5.0 million (40.7%) over the project duration. Conclusion A program providing counseling and no-cost contraception yields substantial cost savings because of the increased uptake of highly effective contraception and consequent averted unintended pregnancy and birth

Show Me My Health Plans: a study protocol of a randomized trial testing a decision support tool for the federal health insurance marketplace in Missouri

BACKGROUND: The implementation of the ACA has improved access to quality health insurance, a necessary first step to improving health outcomes. However, access must be supplemented by education to help individuals make informed choices for plans that meet their individual financial and health needs. METHODS/DESIGN: Drawing on a model of information processing and on prior research, we developed a health insurance decision support tool called Show Me My Health Plans. Developed with extensive stakeholder input, the current tool (1) simplifies information through plain language and graphics in an educational component; (2) assesses and reviews knowledge interactively to ensure comprehension of key material; (3) incorporates individual and/or family health status to personalize out-of-pocket cost estimates; (4) assesses preferences for plan features; and (5) helps individuals weigh information appropriate to their interests and needs through a summary page with “good fit” plans generated from a tailored algorithm. The current study will evaluate whether the online decision support tool improves health insurance decisions compared to a usual care condition (the healthcare.gov marketplace website). The trial will include 362 individuals (181 in each group) from rural, suburban, and urban settings within a 90 mile radius around St. Louis. Eligibility criteria includes English-speaking individuals 18–64 years old who are eligible for the ACA marketplace plans. They will be computer randomized to view the intervention or usual care condition. DISCUSSION: Presenting individuals with options that they can understand tailored to their needs and preferences could help improve decision quality. By helping individuals narrow down the complexity of health insurance plan options, decision support tools such as this one could prepare individuals to better navigate enrollment in a plan that meets their individual needs. The randomized trial was registered in clinicaltrials.gov (NCT02522624) on August 6, 2015

Understanding contributors to racial and ethnic inequities in COVID-19 incidence and mortality rates

BACKGROUND: Racial inequities in Coronavirus 2019 (COVID-19) have been reported over the course of the pandemic, with Black, Hispanic/Latinx, and Native American individuals suffering higher case rates and more fatalities than their White counterparts. METHODS: We used a unique statewide dataset of confirmed COVID-19 cases across Missouri, linked with historical statewide hospital data. We examined differences by race and ethnicity in raw population-based case and mortality rates. We used patient-level regression analyses to calculate the odds of mortality based on race and ethnicity, controlling for comorbidities and other risk factors. RESULTS: As of September 10, 2020 there were 73,635 confirmed COVID-19 cases in the State of Missouri. Among the 64,526 case records (87.7% of all cases) that merged with prior demographic and health care utilization data, 12,946 (20.1%) were Non-Hispanic (NH) Black, 44,550 (69.0%) were NH White, 3,822 (5.9%) were NH Other/Unknown race, and 3,208 (5.0%) were Hispanic. Raw cumulative case rates for NH Black individuals were 1,713 per 100,000 population, compared with 2,095 for NH Other/Unknown, 903 for NH White, and 1,218 for Hispanic. Cumulative COVID-19-related death rates for NH Black individuals were 58.3 per 100,000 population, compared with 38.9 for NH Other/Unknown, 19.4 for NH White, and 14.8 for Hispanic. In a model that included insurance source, history of a social determinant billing code in the patient\u27s claims, census block travel change, population density, Area Deprivation Index, and clinical comorbidities, NH Black race (OR 1.75, 1.51-2.04, p\u3c0.001) and NH Other/Unknown race (OR 1.83, 1.36-2.46, p\u3c0.001) remained strongly associated with mortality. CONCLUSIONS: In Missouri, COVID-19 case rates and mortality rates were markedly higher among NH Black and NH Other/Unknown race than among NH White residents, even after accounting for social and clinical risk, population density, and travel patterns during COVID-19

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

AIM: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. METHODS: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. RESULTS: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. CONCLUSION: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

The genetic architecture of the human cerebral cortex

The cerebral cortex underlies our complex cognitive capabilities, yet little is known about the specific genetic loci that influence human cortical structure. To identify genetic variants that affect cortical structure, we conducted a genome-wide association meta-analysis of brain magnetic resonance imaging data from 51,665 individuals. We analyzed the surface area and average thickness of the whole cortex and 34 regions with known functional specializations. We identified 199 significant loci and found significant enrichment for loci influencing total surface area within regulatory elements that are active during prenatal cortical development, supporting the radial unit hypothesis. Loci that affect regional surface area cluster near genes in Wnt signaling pathways, which influence progenitor expansion and areal identity. Variation in cortical structure is genetically correlated with cognitive function, Parkinson's disease, insomnia, depression, neuroticism, and attention deficit hyperactivity disorder

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Multiorgan MRI findings after hospitalisation with COVID-19 in the UK (C-MORE): a prospective, multicentre, observational cohort study

Introduction: The multiorgan impact of moderate to severe coronavirus infections in the post-acute phase is still poorly understood. We aimed to evaluate the excess burden of multiorgan abnormalities after hospitalisation with COVID-19, evaluate their determinants, and explore associations with patient-related outcome measures. Methods: In a prospective, UK-wide, multicentre MRI follow-up study (C-MORE), adults (aged ≥18 years) discharged from hospital following COVID-19 who were included in Tier 2 of the Post-hospitalisation COVID-19 study (PHOSP-COVID) and contemporary controls with no evidence of previous COVID-19 (SARS-CoV-2 nucleocapsid antibody negative) underwent multiorgan MRI (lungs, heart, brain, liver, and kidneys) with quantitative and qualitative assessment of images and clinical adjudication when relevant. Individuals with end-stage renal failure or contraindications to MRI were excluded. Participants also underwent detailed recording of symptoms, and physiological and biochemical tests. The primary outcome was the excess burden of multiorgan abnormalities (two or more organs) relative to controls, with further adjustments for potential confounders. The C-MORE study is ongoing and is registered with ClinicalTrials.gov, NCT04510025. Findings: Of 2710 participants in Tier 2 of PHOSP-COVID, 531 were recruited across 13 UK-wide C-MORE sites. After exclusions, 259 C-MORE patients (mean age 57 years [SD 12]; 158 [61%] male and 101 [39%] female) who were discharged from hospital with PCR-confirmed or clinically diagnosed COVID-19 between March 1, 2020, and Nov 1, 2021, and 52 non-COVID-19 controls from the community (mean age 49 years [SD 14]; 30 [58%] male and 22 [42%] female) were included in the analysis. Patients were assessed at a median of 5·0 months (IQR 4·2–6·3) after hospital discharge. Compared with non-COVID-19 controls, patients were older, living with more obesity, and had more comorbidities. Multiorgan abnormalities on MRI were more frequent in patients than in controls (157 [61%] of 259 vs 14 [27%] of 52; p&lt;0·0001) and independently associated with COVID-19 status (odds ratio [OR] 2·9 [95% CI 1·5–5·8]; padjusted=0·0023) after adjusting for relevant confounders. Compared with controls, patients were more likely to have MRI evidence of lung abnormalities (p=0·0001; parenchymal abnormalities), brain abnormalities (p&lt;0·0001; more white matter hyperintensities and regional brain volume reduction), and kidney abnormalities (p=0·014; lower medullary T1 and loss of corticomedullary differentiation), whereas cardiac and liver MRI abnormalities were similar between patients and controls. Patients with multiorgan abnormalities were older (difference in mean age 7 years [95% CI 4–10]; mean age of 59·8 years [SD 11·7] with multiorgan abnormalities vs mean age of 52·8 years [11·9] without multiorgan abnormalities; p&lt;0·0001), more likely to have three or more comorbidities (OR 2·47 [1·32–4·82]; padjusted=0·0059), and more likely to have a more severe acute infection (acute CRP &gt;5mg/L, OR 3·55 [1·23–11·88]; padjusted=0·025) than those without multiorgan abnormalities. Presence of lung MRI abnormalities was associated with a two-fold higher risk of chest tightness, and multiorgan MRI abnormalities were associated with severe and very severe persistent physical and mental health impairment (PHOSP-COVID symptom clusters) after hospitalisation. Interpretation: After hospitalisation for COVID-19, people are at risk of multiorgan abnormalities in the medium term. Our findings emphasise the need for proactive multidisciplinary care pathways, with the potential for imaging to guide surveillance frequency and therapeutic stratification

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication